JP2008119489A - Method and apparatus for percutaneously accessing implanted port - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method and apparatus for percutaneously accessing an implanted port. <P>SOLUTION: This method for aligning an access cannula 120 includes: a process of observing an access part on the skin or artificial model at the proximal end of a preliminarily formed access tract 120; and a process of aligning the access cannula 120 with the access part on angular-coaxially with the access tract, wherein the angle is substantially vertical to the skin or the model surface at the access part. The method further includes a process of introducing the cannula 120 through the preliminarily formed access tract and establishing a passage reaching the port through the cannula. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

(Background of the Invention)
1. The present invention generally relates to the design and use of medical devices. More particularly, the present invention relates to devices and methods for accessing an implant port, but such access can be facilitated by properly aligning the access cannula with the patient outside the body. As described below, the present invention generally provides a method and apparatus that allows and facilitates repeated access to an implantation port that does not necessarily require surgical intervention by a trained medical personnel each time. The purpose is to provide.

Access to the patient's vascular system can be established by a variety of provisional and permanent implant devices. More simply, provisional access can be provided by introducing the needle directly percutaneously through the patient's skin and into the blood vessel. Such direct approaches are relatively simple and suitable for provisions such as intravascular delivery, intravascular drug delivery, and other applications that last only for a short period of time, but these are often patient survival It is not suitable for hemodialysis, peritoneal dialysis, hemofiltration, and other extracorporeal treatment procedures that must be repeated periodically over the entire period.

For long-term vascular access suitable for hemodialysis, hemofiltration, etc., a very common approach is to produce subcutaneous arteriovenous (A-V) fistulas. The fistula is preferably provided by anastomosing an artery, usually the radial artery, to a vein, usually the head vein. The vein is dilated and eventually vascularized, making it suitable for repeated perforations with a needle for access purposes. An arteriovenous AV fistula may also be provided utilizing autologous or heterogeneous veins, typically by grafting synthetic blood vessels such as PTFE tubes.

A cannula used to percutaneously access an arteriovenous (A-V) fistula can be a large perforated core needle, often referred to as a fistula needle. As an alternative, fistula access can be obtained using a blunt cannula with a removable trocar or stylet. In either case, the cannula is usually 14
ga. (With a perforation diameter of 1.49 mm) or larger tolerate the high blood flow rates required for hemodialysis, hemofiltration, and other extracorporeal treatment procedures. Typically, a fistula needle or other access cannula is
It is introduced through different parts of the skin. By successively selecting different skin access locations, tissue penetration to the fistula can be healed.

It is known to access arteriovenous fistulas using a “buttonhole” technique that repeatedly approaches the fistula through the same access area. Usually, when the access is complete, reverse bleeding occurs, resulting in a clot that blocks the access area. Such agglomerates must be removed prior to subsequent needle insertion to avoid the risk of pushing the agglomerates into the fistula. Clot removal requires the use of tweezers or other equipment to withdraw “clot clot thrombus” from the area, risking infection and causing patient discomfort and bleeding. Furthermore, there is still a risk of embolism if removal is incomplete. Buttonhole technology involves the need to remove clots, but is difficult to master and requires a trained assistant to perform both the initial area cleaning process and the subsequent needle approach.

Buttonhole technology, when performed by skilled personnel, can be successful and results in less pain to the patient once the access channel is established, but is a very difficult procedure to learn . In particular, since the user cannot see or feel the entry point on the fistula, each time the needle is properly aligned to pass exactly through the established tissue area to reach the same location on the fistula Is extremely difficult. Due to the need to repeatedly pass the needle through the established tissue area, it is recommended that the buttonhole technique should be performed with the same “striker” each time. Usually this means that buttonhole technology is only used by home users, in which case the patient or full-time assistant may perform a needle push each time dialysis is performed. However, such requirements limit the use of buttonhole technology to a large extent, since most dialysis is performed on medical records.

As an alternative to the use of arteriovenous (A-V) sputum, a variety of implantable ports have been proposed over the years for use in hemodialysis, hemofiltration, and other extracorporeal treatments. Typically, this port includes a chamber having an access region, such as a septum, where the chamber is attached to the implanted cannula, which in turn is secured to the blood vessel. For veins, the cannula is typically internal, and for arteries, the cannula can be attached by conventional surgical techniques.

However, percutaneous access to the port through the septum is generally limited to small diameter, non-coring needles. Large diameter needles core the septum, i.e., form a permanent channel therethrough, which breaks the septum after repeated use. Small diameter non-coring needles allow the septum to heal after the needle has been removed with little or no material removed from the septum. Thus, although small needles protect the septum, these needles are generally incompatible with the high flow rates employed for vascular dialysis and other extracorporeal treatments.

An implantable port having an access opening and an internal valve mechanism for isolating the implantation cannula has also been proposed. One type of implantable valved port is described in a series of issued U.S. patents named William Enminger as the inventor. The access port of the Ensinger patent has an internal lumen for receiving a percutaneously introduced needle and an internal valve structure for isolating the port from the associated implantable cannula. In general, the ports of the Ensinger patent have a needle-receiving opening that is oriented at an angle of inclination relative to the patient's skin.
The port of the Ensinger patent employs a relatively large funnel-shaped inlet port, allowing the needle to be introduced through many different locations according to conventional treatment procedures. The Ensinger patent does not describe port approach using a large diameter centering needle, such as a fistula needle. In addition, certain Ensmin
Since many of the ger patent designs employ elastomeric valve elements, if a fistula needle or other large perforated centering needle approaches the port,
The valve mechanism can be damaged. Representative Ensinger patents are listed in the Background section below.

To date, hemodialysis, where large amounts of blood, dialysate, or other fluids are exchanged,
With the implementation of peritoneal dialysis or other treatment procedures, the implantable port has not been recognized for widespread acceptance. As long as an implantable port is used, the skin is moved relative to the port to move the access location through the skin and / or to change the location of the tissue area between successive access procedures. It is generally recommended.

The present invention generally eliminates the need to repeatedly puncture the skin, or to pierce ports that do not need to be pierced at multiple locations and that do not require the intervention of highly trained medical practitioners. It is an object to provide an essentially non-surgical method and corresponding apparatus for establishing access. The present invention is suitable not only for access to the patient's vasculature, but also for access to other body lumens, cavities, and tissue target locations, for subsequent treatment, diagnosis, or We seek to provide an approach that allows other methods to be implemented. The access method according to the present invention can also be used for non-medical purposes such as testing or repairing an implantation port, for example.

The present invention provides the following:
(1) A method of aligning access cannulas, the method comprising:
Observing an approach site on the skin or artificial model at the proximal end of the preformed approach tract;
Aligning the access cannula with the access site at an angle coaxial with that of the access tract.
(2) The method according to item 1, wherein the angle is substantially perpendicular to the skin or the model surface at the approaching portion.
(3) The method of item 1 or item 2, further comprising the step of introducing a cannula through the preformed access tract to establish a flow path through the cannula to a port.
(4) The port according to any one of items 1 to 3, wherein the port includes an opening, and the arranging step includes manually aligning the cannula with a line from an entry point of the approaching tract to the opening of the port. The method described.
5. The method of claim 4, wherein the opening has a dimension corresponding to the cannula.
(6) The method according to item 4, wherein the arranging step further includes a step of manually looking up the port to define a position of the opening.
(7) The method according to any one of items 1 to 6, wherein the introducing step includes the step of orienting the cannula in a direction substantially perpendicular to the skin or the model surface.
(8) A method according to any of items 1 to 7, wherein the cannula is introduced through a skin layer having a thickness in the range of 3 mm to 20 mm.
(9) The method according to any one of items 1 to 8, wherein the port has an internal valve that suppresses reverse bleeding into the access tract after the cannula is withdrawn.
(10) A method according to any of items 1-9, wherein the cannula expands when introduced through the access tract.
(11) A method according to item 8, wherein the cannula has a perforation dimension of at least 1.16 mm.
(12) A method according to item 1, wherein the cannula comprises a needle.
(13) A method according to item 1, wherein the cannula comprises a blunt tube.
14. The method of claim 11, wherein the cannula further comprises a stylet that is removably received in the blunt tube.
(15) The method according to any one of items 1 to 14, further comprising the step of testing or repairing the implanted port through the flow path.
(16) advance the access cannula through the preformed access tract and into the implantable access port to access the port while establishing fluid communication between the cannula and the port; Open the closure element of
Withdrawing the cannula and then advancing another cannula through the access tract to the port.
(17) (1) while advancing and inserting an access cannula into an implantable vascular access port or peritoneal access port and accessing the port;
Simultaneously, opening the normally closed closure element of the port, (2) exchanging fluid between the cannula and the port, and (3) the access from the port Withdrawing the cannula and allowing the valve to close;
With the access cannula moving along the same access tract, the step (1)
To (3) is repeated.
(18) Use of an implantable access port with an actuable closure element biased to a closed position, in which the access cannula repeatedly approaches the port along the same access tract for treatment In a process, the port is connected to a blood vessel, the process comprising removing blood from the patient through the port, processing the blood, and returning the blood to the patient through the port.
(19) Use of an implantable access port in which an actuable closure element is biased to a closed position, wherein the access cannula repeatedly approaches the port along the same access tract for treatment In the process, the port is connected to the peritoneum, the process introduces dialysate into the patient through the port, and then
Removing the dialysate from the patient through the port.
(20) A method of forming an access tract leading to an implanted port, the method comprising:
Transcutaneously introducing a cannula to define an approach tract having a skin entry point and extending to the port;
Repeatedly contacting the port with the cannula through the same access tract at sufficient intervals and for a sufficient period of time to produce wound tissue formation over the access tract.
(21) The method according to item 20, wherein the approaching step includes introducing a cannula at an interval of at least twice a week for a period of at least 3 months.
(22) A method according to item 20, wherein the approaching step includes introducing a cannula at an interval of at least twice a day for a period of at least 3 months.
(23) The method according to any one of items 20 to 22, wherein the introducing step includes the step of orienting the cannula in a direction substantially perpendicular to the skin surface.
(24) A method according to any of items 20 to 23, wherein the cannula is introduced through a skin layer having a thickness in the range of 3 mm to 20 mm.
(25) Item 20 to Item 2 wherein the port has an internal valve that inhibits reverse bleeding into the tissue tract after the cannula is withdrawn.
26. A method (26) according to any of items 4, wherein the cannula is expanded when introduced through the access tract.
27. The method of claim 26, wherein the cannula has a perforation dimension of at least 1.16 mm.
28. A method according to any of items 20 to 27, wherein the cannula comprises a needle.
(29) A method according to any of items 20 to 27, wherein the cannula comprises a blunt tube.
30. The method of claim 29, wherein the cannula further comprises a stylet that is removably received by the blunt tube.
(31) A method of providing an access tract leading to a port implanted subcutaneously, the method comprising:
Implanting a port into a subcutaneous tissue pocket, wherein an access cannula receiving opening of the port is placed under an intact area of skin;
Introducing a penetrating element into the opening through the intact area of skin, wherein the element is maintained secured to the opening for a period of time sufficient to provide an access tract. .
(32) Item 31 wherein the sufficient period is at least one week.
The method described in 1.
33. The item 31 and the item 31, wherein the penetrating element is an access cannula, and the method further comprises introducing or removing fluid through the access cannula while the cannula is secured to the opening. Item 32
A method according to any of the above.
(34) Use of an implantable access port in making a subcutaneous implant that allows access to a patient's vasculature or other body region, wherein the transplant is directed to the patient's vascular or other body region. And is disposed at the distal end of the percutaneous access tract so that it can be repeatedly accessed by a cannula through the access tract, the port including an actuable closure element, the cannula and the Applications that are arranged to provide repetitive exchange of fluids between patient vessels or other body regions and to close again upon withdrawal of the cannula.
(35) A transcutaneous access system comprising a device enclosed in subcutaneous tissue and providing fluid communication with a body region, the device including a pre-established receptacle and in alignment with the receptacle A system that receives a cannula through a tract and couples the cannula in fluid communication with the body region through the device.
36. The system of claim 35, wherein the tract extends continuously from the skin surface of the receptacle.
37. A system according to item 35, wherein the tract is present when the cannula is not present.
(38) A system according to item 35, wherein the tract is surrounded by wound tissue.
(39) A system according to item 35, wherein the tract is surrounded by wound tissue.
40. The system of claim 35, wherein the tract comprises a slit when the cannula is not present.
(41) An implantation port disposed under a preformed access tract, the port including an operable closure means, and a cannula inserted at least partially into the port through the preformed access tract An implanted port wherein the inserted cannula provides fluid communication between the cannula and the port to bias the closure means to an open position.
(42) a cannula;
Instructions for use that clearly indicate the method described in item 1,
A kit comprising the cannula and a package containing the instructions for use.
(43) The kit according to Item 42, further comprising a catheter connected to or connectable to the cannula.
(44) a cannula;
Instructions for use that clearly indicate the method described in item 20, and
A kit comprising the cannula and a package containing the instructions for use.
45. A kit according to Item 44, further comprising a catheter connected to or connectable to the cannula.
(46) a subcutaneously implantable port;
Instructions for transplanting the port according to the method of item 31;
And a package containing the port and the instructions for use.
(47) A kit according to item 46, further comprising a penetrating element.
48. A kit according to item 47, wherein the penetrating element comprises an access cannula.
(Summary of the Invention)
The present invention includes hemodialysis, hemofiltration, hemofiltration dialysis, apheresis, peritoneal dialysis,
Improved methods, devices, and kits are provided for providing and establishing access to subcutaneously implanted ports for a variety of purposes, including drug delivery and the like. This method relies, at least in part, on a surprising discovery, that is, a self-closing access port implanted subcutaneously using an access cannula, including but not limited to a large perforated diameter needle. As a result of repeated percutaneous penetration, the tissue can be provided with a mandibular passage with reduced or no reverse bleeding after the cannula has been removed. Once established, it effectively eliminates the need to surgically introduce a needle through the patient's skin. As the tissue section loses its neural sensitivity over time, the patient's trauma is reduced or eliminated.

The tissue area utilized by the present invention does not produce the same type of tunnel that occurs over time when using the “button hole” fistula approach technique described above. In particular, the tissue area formed by the present method is usually reduced or free of clot clot formation, thereby eliminating the need to remove clot thrombus, at least in most cases, And the risk of emboli release is significantly reduced. The cause of such agglomeration is due, at least in part, to the ability of the valved port or other self-closing port to inhibit back bleeding into the tissue area when the needle is withdrawn, Is believed. Inhibition of reverse bleeding reduces or eliminates clot and crust formation beyond the penetration point and through the access area. Thus, the ability to remove crust removal or the ability to reduce crust removal is a significant benefit for the patient. In addition, by utilizing the preferred access port of the present invention, the tissue section can be formed vertically, thus reducing length and further reducing bleeding and patient trauma. The access port is also particularly easy to place under the skin, and when combined with the ability to introduce the needle vertically, the process of directing the port to the target is greatly simplified. The ability to accurately and easily direct the port to the target reduces the chance that the cannula is misdirected, further reduces patient trauma, and improves the formation of the unique tissue area underlying the present invention.

According to a first aspect of the present invention, a method for accessing a patient's implantation port includes the process of placing a preformed access tract extending from the entry point on the surface of the patient's skin to the port. Pre-formed access tracts typically have a healed luminal surface that, once formed, penetrates, resects, or otherwise surgically deforms the patient's skin or tissue. Allows subsequent access to the transplant port without the need for In particular, once the port has been implanted and an access tract has been formed, the process of approaching the port can be performed essentially by a technician without expert surgical training or even by the patient himself. This is a non-surgical process. Such access reduces patient trauma, minimizes the risk of infection, and greatly reduces the risk of embolism associated with previous buttonhole access to the arteriovenous (A-V) fistula.

In particular, the method includes first observing an approach site on the patient's skin surface that is present at the proximal end of the preformed access tract. The access cannula is then aligned with the access site at an angle that is coaxial with the orientation of the access tract. Usually, the access cannula is aligned directly across the access site and is held in a generally perpendicular direction to the skin at that site. The access cannula is then introduced through a preformed access tract to establish a flow path through the cannula to the port. As mentioned above, over time, repeated percutaneous introduction of the cannula provides a unique tissue tract that parallels the scar tissue and appears to have reduced neuronal sensitivity and angiogenesis. It remains open during continuous access, thus reducing patient trauma as the same tissue tract continues to be used for access. The tract is currently thought to be in parallel with tissue with reduced nerve presence and angiogenesis, but the benefits of the present invention do not depend on these specific features, and the tract is paralleled. Achieved regardless of the exact nature of the tissue to be shaped.

The port typically has an opening for receiving the cannula, and the alignment process is a line from the skin entry point (which remains visible on the surface of the patient's skin) to the opening on the port. And manually aligning the cannula, wherein the opening can be manually placed by obtaining the feel of the port through the patient's skin and determining the position of the opening. Typically, the opening has a dimension that corresponds to the dimension of the cannula, for example, may have the same diameter, but in other cases, the opening has a funnel having a dimension that is substantially larger than the cannula diameter. Is provided. However, it is usually undesirable to provide such a funnel to direct the cannula into the opening. This is because the funnel allows the user to penetrate the cannula through different access tracts.

The cannula may comprise a needle with a sharpened or chamfered distal tip to allow self-penetration of the cannula through the patient's skin. Alternatively, the cannula may comprise a blunt tubular body and optionally a trocar, stylet, blade, or other sharp element to assist in self-introduction of the cannula. In some cases, it may not be necessary to provide a sharpening element on the cannula to assist percutaneous introduction after the access tract has been established. That is, the blunt cannula can be passed inward through the established tissue tract. Typically, the cannula has a diameter that is larger than the diameter of the tissue tract that collapses after the cannula is removed in previous treatment protocols. Thus, when the cannula is introduced through the established tissue tract, the tissue tract is expanded.

In the illustrated embodiment, the cannula is a large perforated cannula, typically at least 1.16 mm (16 gauge), preferably at least 1.33.
mm (15 gauge), more preferably at least 1.55 mm (14 gauge)
In some cases at least 1.73 mm (13 gauge) and in other cases at least 2.80 mm (12 gauge). In particular, the cannula can be a large perforated fistula or other needle having these dimensions.

The above-described method for aligning the access tract and the access cannula or, if necessary, for introducing the cannula through the tract instead of or in addition to performing the extracorporeal treatment protocol described above. Can be implemented for various purposes. For example, the method can be implemented on a cadaver or artificial treatment model to train medical personnel and / or the patient on how to perform cannula access techniques. Thus, such non-clinical methods have significant utility within the specification of the present invention.

In a second aspect of the invention, a method for creating a percutaneous access tract leading to an implantation port includes introducing a cannula percutaneously to initially define the access tract. This access tract has a skin entry point and extends to the port, typically extending to an opening on the port as generally described above. The approaching tract is cannulated with a cannula (usually the same or different geometric shape) through the same approaching tract at sufficient intervals and for a sufficient period of time to cause scar formation over the approaching tract. Established by repeated access to different cannulas) ports, which may have dimensions, etc. Usually, the access interval and duration will depend, at least in part, on the procedure to be performed on the patient. For example, patients undergoing hemodialysis typically have an interval of at least twice a week, more usually 1
It has a cannula introduction process that is repeated four times a week for a period of at least 3 months, usually an indeterminate period. For patients undergoing peritoneal dialysis, the access interval is much more frequent, usually at least twice a day, often at least four times a day, at least three months, typically indefinite periods, repeated Is done.

Usually, although not required, the cannula is introduced in a consistent direction, for example, substantially perpendicular or perpendicular to the skin surface through which the cannula is introduced, and the repeated depletion process eventually results in the aforementioned neurodepleted tissue tract Occurs. After formation of this tract, it may be preferable to use a cannula with a blunt (or blunt) tip for subsequent access. The availability of preformed access tracts reduces or eliminates the need for sharp tips (or separate stylets), and the use of blunt cannulas Reduce the risk of cutting to the luminal surface.

In a third aspect of the invention, a method of providing an access tract when a port is first implanted includes the step of implanting the port in a subcutaneous tissue pocket,
The access cannula receiving opening of the port is placed under an intact area of skin. This is usually accomplished by providing an initial surgical incision that is horizontally offset from the main portion of the tissue pocket so that the port is placed under the skin that was not penetrated by the surgery. Can be done. After the port is in place, the penetrating element can be introduced through the intact area of the skin and into the port opening. The penetrating element is
It can be a rod, tube, or preferably an access cannula of the type used for subsequent access to the port, but is left in place for a time sufficient to provide an access tract, usually at least about 1 A week, more usually at least about 2 weeks, and until sufficient healing has occurred around the penetrating element, remains anchored in the opening, leaving an access tract for subsequent cannula introduction. A particular advantage of this method for providing an access tract is that the tract is formed simultaneously with the surgical introduction of the port and the associated subcutaneous cannula healing. A further advantage is that if an access cannula is used as the penetrating element, fluid can be introduced into and removed from the port during the healing period.

In a further aspect of the invention, a percutaneous access system comprises a device enclosed in subcutaneous tissue and provides fluid communication with a body region. The device includes a pre-established receptacle, such as the cannula receiving opening described above, receives the cannula via a tract aligned with the receptacle, and couples the cannula in fluid communication with the body region via the device. . This tract is pre-formed and, in parallel with the scar tissue, preferably protects the underlying tissue to provide non-surgical access to the receptacle, as described above. This device is usually an implanted port placed under a preformed access tract, and the port preferably includes an operable closure means. The system optionally includes a cannula that is at least partially inserted into the port via a preformed access tract. The inserted cannula biases the closure means to the open position to provide fluid communication between the cannula and the port, and the closure means closes when the access cannula is retracted. Suitable closure means are also described above.

The present invention further provides a kit with a cannula, which often has a perforation size of at least about 1.16 mm (16 gauge), such as a fistula needle or a blunt cannula with a trocar or stylet. Large perforated cannula. The kit further includes instructions for specifying any of the methods described above. The needle and instructions for use are packaged together, where the instructions may be on a separate instruction sheet and / or provided as part of the package. Usually the cannula is part of the catheter,
In this case, the needle is connected to or connectable to the catheter and provides a flow path through the needle and into the lumen of the catheter. The kit of the present invention may also comprise an implantable port with instructions for use in demonstrating any of the methods described above for implanting the port and providing a cannula access tract to the port. The ports and instructions for use are typically packaged together using any of the packages described later herein, and other kit components such as penetrating elements, access cannulas, etc. are also provided. obtain.

(Description of specific embodiments)
The method and apparatus for providing and utilizing a percutaneous access area of the present invention include:
Large perforated cannulas, such as fistula needles, include, but are not limited to, useful with any type of implantable access port that has an opening capable of receiving a cannula. The method of the present invention can be one, two, three or more that can be repetitively aligned in a direction perpendicular to the access area to be formed through the overlying tissue percutaneously or otherwise. Can be implemented using an implantable port having more than a discontinuous access port. Such access areas are useful for repetitive access to the opening, where the opening penetrates the upper tissue and defines a specific target location.

Preferred access ports have at least one opening that removably receives the access cannula, optionally in a vertical orientation, to minimize the distance of the tissue section. The access port is preferably capable of immobilizing the access needle while blood is being transported through the port. The specific access port was 1997 1
Co-pending application Ser. No. 08 / 942,990, filed on 02 Feb., which is incorporated herein by reference, which is incorporated herein by reference.
This was a partial continuation application of / 036,124. Typically, the port is about 3m
Implanted under the skin by a distance in the range m to 20 mm, usually in the range 5 mm to 15 mm.

The access cannula utilized in the methods, devices, and kits of the present invention may comprise any of a variety of hollow piercing needles, tubes, etc., which can be percutaneously into a previously implanted port. Has the ability to be introduced automatically. Typically, the cannula is a sharpened distal end (in this case, the cannula is often referred to as a needle) or a separate element that can be removably placed on the cannula to provide such a sharpened distal end. Is provided. Such elements may comprise stylets, trocars, blades and the like. In one example, the tip of the separate element may have a diameter that is larger than the diameter of the cannula itself. For example, a blade having a width greater than the cannula diameter may be placed on the cannula using a rod to cut the path as the cannula and blade assembly is advanced through the tissue section. In such an example, the blade is typically sufficiently flexible so that it is later collapsed to provide an unobstructed access to the port through the cannula lumen and the cannula Through the proximal end. A cannula having a sharp distal end or a separate element having a sharp distal end is typically used at least during the initial percutaneous access step during which the tissue section is being formed. After the tissue area is established, i.e. sufficient wound tissue has been formed along the tissue area, sufficient wound tissue to maintain the area during successive access steps using the cannula It is not always necessary to provide a sharp tip on the cannula or separate element. In these examples, a blunt cannula or tube can be introduced through the tissue section. However, often
It is still preferred to facilitate such an introduction process using a cannula having a sharpened tip or a separate element.

Specific embodiments of the present invention utilize large perforated centering needles, such as conventional fistula needles. In the term “coring needle”, the distal tip of the needle is sharpened and opened forward, resulting in the ability to cut tissue as the needle is advanced forward therethrough That means. Hubers with side-facing distal openings as well as stylets (hubs)
er) Needles having an uncentered design such as needles can also be used in the present invention. Preferred needles and other cannulas are at least 1.1.
6 mm (16 G), usually at least 1.33 mm (15 G), more usually at least 1.55 mm (14 G), and more usually at least 1.73
It has a perforation size of mm (13G), sometimes on the order of 2.08 mm (12G) or larger. The needle need only be composed of a conventional needle material and is typically stainless steel, but may be a hard plastic.

In a preferred embodiment, the access needle is a co-pending application Ser. No. 08/896,
Incorporated into a catheter as described in US 790, or into a peritoneal dialysis tubing set as described in co-pending application Ser. No. 08 / 896,791, both of which are fully disclosed. , Previously incorporated herein by reference. Such a catheter incorporating an access needle will now be described in detail, along with a method for use according to the present invention.

Referring now to FIGS. 1 and 2, an access catheter 10 incorporating a large perforated centering needle 20 in accordance with the principles of the present invention will be described. Catheter 10
Comprises a catheter body 12 having a proximal end 14 and a distal end 16. The catheter body 12 is typically composed of a medically compatible organic polymer such as polyvinyl chloride, and has a length in the range of 10 cm to 30 cm, preferably in the range of 12 cm to 18 cm, and in the range of 1 mm to 5 mm. With a flexible polymer tube, usually having a lumen diameter in the range of 3.4 mm to 4.6 mm. Such a polymer tube can be formed by extrusion and typically includes a single lumen that extends the entire length from the proximal end 14 to the distal end 16.

The attachment 18 is secured to the distal end of the catheter body 12 typically by adhesive, heat welding, solvent bonding, a through fastener (not shown), or other conventional means. The fixture is shown as a generally flat disc, but can have a variety of alternative geometric shapes. The access tube 20 is affixed to the distal front face of the disc, and the needle lumen is fluidly connected to and aligned with the lumen of the catheter body 12.
Openings 25 are located in the disc 18 and are generally aligned between the needle lumens 21;
Accordingly, the catheter body is opened to the lumen 27. Usually, a connector 26, such as a luer connector, is connected to the proximal end 1 of the catheter body 12.
4 is provided. However, such a connector is not necessary, and it is possible to connect the catheter body directly to the desired treatment device, fluid source, or other external device.

The compressible element 30 is attached to the distal end 16 of the catheter body 12 as described in detail in co-pending application 08 / 896,790. The compressible element is preferably arranged coaxially around the proximal end of the needle 20. The compressible element 30 only needs to be infiltrated with a disinfectant, antibiotic, or other active agent,
These drugs can be transported there as the needle 20 is penetrated through the skin surface. Such compression elements are generally preferred for use in combination with the needles of the present invention, but do not form part of the present invention.

Referring now to FIG. 3, an alternative configuration 16 ′ at the distal end of the catheter 10 orients the access needle 20 at a generally right angle (90 °) relative to the distal end of the catheter body 12. The fitting 18 includes a cap 32 having an inlet 34 for receiving the distal end of the catheter body 12 and an outlet 36 connected to the fitting 18 to define a 90 ° bend. The catheter body 12 can extend through the internal passage of the cap 32 or, alternatively, can be secured at the entry end. In any case, a substantially continuous lumen 27 is provided through the catheter body to the opening 25 and the fitting 18 and thus to the lumen 21 of the access needle 20.

Referring now to FIG. 3A, a second alternative configuration 11 at the distal end of the catheter 10
6 is generally perpendicular (90 °) to the distal end of the catheter 10 and the blunt distal end 1
The access cannula 120 having 22 is oriented. The fitting 118 receives the catheter 10 with a nipple 124 that is aligned perpendicular to the vertical passage 126. The through closure 128 is positioned at the upper end of the passage 118 and allows for the removable entry of the stylet 130 having a sharp distal end 132 that extends through the blunt end 122 of the cannula 120. The stylet includes a handle 134 at its proximal end to allow removal of the stylet after the cannula 120 has been introduced through the tissue section into the implantation port. The pointed tip 132 of the stylet may take any of the forms described above, through a conical taper shape, a chamfered taper shape, a wide blade, or through the skin as the cannula is advanced toward the implantation port. Any other configuration that facilitates penetration of the cannula 120 and stylet 130 assembly is included. The dimensions of the cannula 120 are usually within the previously specified range, but not necessarily within that range.

Referring now to FIGS. 4A-4D, use of a catheter 10 having a distal end 16 '(FIG. 3) and an access needle 20 for providing an access tract and accessing the implantation port P through the access tract. Is explained. Port P has an opening A that is preferably oriented to receive a vertically aligned needle.
That is, the approaching needle 20 is perpendicular to the plane of the skin at the point where the needle is introduced,
Alternatively, it is preferably introduced percutaneously through the skin surface S in a direction perpendicular thereto. While vertical access is preferred and can be achieved using the specific ports of the present invention, percutaneous access according to the present invention can also be achieved using non-vertical access directions, i.e. In this case, access is achieved by penetrating a needle or other device at a relatively small angle to the skin, often between 15 ° and 45 ° to the skin surface. After entering port P, the access needle 20 activates an internal valve (not shown) to open the flow path with the lumen and cannula C, where the cannula is 15 May 1997. It may be connected to a blood vessel or other body lumen or cavity, as described in detail in co-pending application Ser. No. 08 / 856,641, filed on date. The present invention is useful with a variety of other valved or valveless access ports. For example, issued US Pat. No. 5,741,
No. 228, No. 5,702,363, No. 4,569,675, No. 4,534,
795, 4,181,132, and published PCT application WO 97
Although the ports described in US Pat. No. 4,473,338 and WO 96/31246 are useful from the outset, valved access ports of the type described in the Ensinger patent listed earlier, all disclosures of the above patents Are incorporated herein by reference. Disclosed is the use of a valved port for secure blockage and isolation of an attached body lumen, and in particular for complete stoppage of reverse bleeding when the access cannula is removed from the port attached to the blood vessel. However, the present invention also recognizes applications for use with other self-sealing ports such as septum ports, many of which are described in the patents listed in the background section of this application. Access needle 20 is port P
Can be aligned across the aperture A by hand sensing the top of the. The user
The periphery of the port P can be sensed and its center can be visually determined. The needle 20 is then vertically penetrated through the skin and into the opening, as shown in FIG. 4B. The thickness of the tissue T in the upper layer of the opening is generally 3 mm to 15 mm as described above.

Needle 20 is left in place at port P while the desired procedure, such as hemodialysis, hemofiltration, peritoneal dialysis, or other procedure is performed and completed. After the treatment procedure is complete, the needle 20 is withdrawn as illustrated in FIG. 4C. The withdrawal of the needle leaves a tissue tract TT that passes through the tissue T on top of the port P. Since the internal valve of port P is closed, bleeding from the body lumen, typically bleeding from the blood vessels, is substantially or completely suppressed. Both the vertical orientation of the needle invasion and the suppression of reverse bleeding to the tissue tract left after withdrawal of the needle reduces or eliminates crust formation and crust reduction in the patient's trauma, as well as non-fibrous aspects Contributes to rapid healing. Surprisingly, such benefits can be achieved even with the preferred large drilling access needle described above. Rapid healing and minimal trauma were recognized even when the port was approached as many as 4 times per day. Such a result provides considerable advantages over the use of non-coring needles that cannot be predicted prior to the present invention and are typically used with an implant port.

As shown in FIG. 4C, the tissue tract remaining after the withdrawal of the catheter is effectively the second as shown in FIG. 4D immediately after the first catheter is withdrawn.
Ready to receive a catheter. Typically, an additional access needle 2
Zero and associated catheters are introduced over a period of 2 hours to 4 days, usually 4 hours to 2 days. Such cycle times are suitable for performing a wide range of periodic treatment procedures such as hemodialysis, hemofiltration, and peritoneal dialysis.

As just described, the tissue tract of the present invention can be established any time after the port is implanted subcutaneously. In many instances, it is desirable to begin providing tissue tracts when the port is first implanted. Referring to FIGS. 4E to 4G, port P may be either the valved or valveless port described above, but incises skin S and forms a pocket laterally from the incision. To provide a tissue pocket PT. Next, port P is pocket PT
Can be connected to the cannula in any manner. A presently preferred embodiment of connecting port P to cannula C is the co-pending application 09 / __.
________ (__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ (Attorney reference number 177, filed with ________
No. 42-002800), the entire disclosure of which is hereby incorporated by reference. After the tissue pocket PT is closed, the intact skin area IR is in the upper layer of the access cannula target opening A, as shown in FIG. 4F. The tissue penetrating element may be a needle, rod, stylet, tube, or virtually any other penetrating element, but then introduced through the intact area IR of the skin, as illustrated in FIG. 4G. Can be done. In FIG. 4G, the access cannula 16 ′ is used as a penetrating element, but it will be appreciated that this is not necessary for initial tissue tract formation. However, the use of an access cannula is preferred because it allows blood or other fluids to be exchanged through the implantation port from a very short time after implantation of the port. The penetrating element is left in place percutaneously through the skin for a period sufficient to at least begin to form a tissue tract, usually at least 1 week, preferably at least 2 weeks. After that initial time, the tissue penetrating element can be removed and the resulting tissue tract is approached using an access cannula according to the method of the present invention described above. Port P through the implemented organization tract
This continuous approach continues to cause damage and denervation of the tissue tract and, over time, further establish and define the tissue tract. After some time, the passage of the cannula through the tissue tract is somewhat similar to placing an earring on the pierced ear, with much less trauma.

Unlike previous access devices, the pre-formed tissue tract T comprises a tube surrounded by wound tissue that extends continuously from the skin surface to the port. Scar (scar)
tub) forms a tissue tract, but directly communicates with the port and either closes the interior of the tract that must be removed by needle processing without being interrupted by the growth of intervening wound tissue or wound tissue pockets, or otherwise. Form a dead end there. Surprisingly, by repeatedly inserting and removing penetrating elements through a single approach tract T, the body treats the tract T and port as a single permanent implant, which needs to be surrounded by wound tissue There is no need to be blocked by it. Physiologically, the tract T is a slit rather than a hole, which temporarily closes when the penetrating element is removed. Interstitial fluid or lymph appears to circulate through this wound tube, and at first glance, the slits are glued together (during insertion of the penetrating element) to serve to fight infection.

As an alternative, the tract T uses an eco-compatible implantable tubular graft material,
Can be implemented.

Referring now to FIG. 5, the needle 50 is typically not a large perforated cored needle, but in accordance with the present invention, instructions for use (IFU) in the kit.
) And can be packaged as illustrated in FIG. A conventional package, which can be a pouch 52 or any other suitable package such as a tray, box, tube, etc., can be used to contain the needle 50 and IFU, where I
The FU can be printed on a separate sheet and / or printed on the packaging material itself. Optionally, but not necessarily, the needle can be sterilized inside the package, for example by irradiation or ethylene oxide. The instructions may specify any aspect of the method of the invention described above.

Referring now to FIG. 6, port P can be packaged with instructions for use (IFU) in the kit. Conventional package 100 may be in the form of a pouch, tray, box, tube, etc., but may be used to encompass both ports and instructions for use.
Additional kit components such as penetrating elements, access cannulas, etc. may also be included in the kit. Optionally, but not necessarily, any kit component can be sterilized inside the package, and instructions for use can be specified on a separate paper sheet and / or on the packaging itself. The instructions may specify any aspect of the present invention for implanting a port using an access cannula as described above, or subsequently accessing the port.

While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be employed. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

FIG. 1 is a perspective view of a first embodiment of an access catheter having a large diameter cored needle suitable for use in the methods and kits of the present invention. FIG. 2 is a detailed view of the distal end of the catheter of FIG. 1 showing a cross-section of the access needle. FIG. 3 is a detail view of an alternative distal end of the catheter of FIG. 1 showing a cross-section of the access needle. FIG. 3A is a detailed view of the distal end of an alternative access cannula that may be utilized in the methods and kits of the present invention. FIG. 4A is a diagram illustrating the use of the access needle and catheter of FIGS. 1-3 to provide and access a subcutaneous implant port according to the method of the present invention. FIG. 4B is a diagram illustrating the use of the access needle and catheter of FIGS. 1-3 to provide and access a subcutaneous implant port according to the method of the present invention. FIG. 4C illustrates the use of the access needle and catheter of FIGS. 1-3 to provide and access a subcutaneous implant port according to the method of the present invention. FIG. 4D is a diagram illustrating the use of the access needle and catheter of FIGS. 1-3 to provide and access a subcutaneous implant port according to the method of the present invention. FIG. 4E illustrates an alternative technique for providing and accessing a subcutaneous implant port according to the method of the present invention. FIG. 4F is a diagram illustrating an alternative technique of providing and approaching a subcutaneous implant port in accordance with the method of the present invention. FIG. 4G illustrates an alternative technique for providing and accessing a subcutaneous implant port according to the methods of the present invention. FIG. 5 is a diagram illustrating a kit according to the present invention comprising a large perforated centering needle, package, and instructions for use. FIG. 6 is a diagram illustrating a kit according to the present invention with instructions for use, illustrating a method for providing a subcutaneous implant port, package, and access area according to the present invention.

Claims (5)

A cannula,
Instructions for use, clearly showing how, and
A package containing the cannula and the instructions for use,
The method
Observing an access site on the skin or artificial model at the proximal end of a preformed access tract formed by scar tissue produced by repeated skin perforations to approximately the same location of the cannula;
Aligning the access cannula with the access site at an angle coaxial with that of the access tract. The kit of claim 1, further comprising a catheter connected to or connectable to the cannula. A cannula,
Instructions for use, clearly showing how, and
A package containing the cannula and the instructions for use,
The method
Introducing a cannula percutaneously to define and extend an access tract having a skin entry point formed by scar tissue formed by repeated skin perforations to approximately the same location of the cannula and extending to the port; Wherein the tract is oriented along a vertical axis relative to the surface of the skin, the step through the same access tract at a sufficient interval and for a sufficient period of time to produce wound tissue formation over the access tract. Repetitively approaching the port with the cannula. The kit of claim 3, further comprising a catheter connected to or connectable to the cannula.     A method and apparatus for percutaneous access to an implantation port as described herein.

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